NDC 52584-086

INFED

Iron Dextran

INFED is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by General Injectables & Vaccines, Inc.. The primary component is Iron Dextran.

• Product ID: 52584-086_45155e45-1b1f-4ce1-809a-21c9ac93bbac
• NDC: 52584-086
• Product Type: Human Prescription Drug
• Proprietary Name: INFED
• Generic Name: Iron Dextran
• Dosage Form: Injection
• Route of Administration: INTRAMUSCULAR; INTRAVENOUS
• Marketing Start Date: 2019-01-21
• Marketing Category: NDA / NDA
• Application Number: NDA017441
• Labeler Name: General Injectables & Vaccines, Inc.
• Substance Name: IRON DEXTRAN
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Iron [CS],Parenteral Iron Replacement [EPC],Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52584-086-01

1 VIAL, SINGLE-DOSE in 1 BAG (52584-086-01) > 2 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-01-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52584-086-01 [52584008601]

INFED INJECTION

• Marketing Category: NDA
• Application Number: NDA017441
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-01-21

Drug Details

Active Ingredients

Ingredient	Strength
IRON DEXTRAN	50 mg/mL

OpenFDA Data

• SPL SET ID: 3cbcd123-0097-4778-98df-09371837c3a6
• Manufacturer:
  • General Injectables & Vaccines, Inc.
• UNII:
  • 95HR524N2M
• RxNorm Concept Unique ID - RxCUI:
  • 206216
  • 311144

Pharmacological Class

• Iron [CS]
• Parenteral Iron Replacement [EPC]
• Phosphate Binder [EPC]
• Phosphate Chelating Activity [MoA]

NDC Crossover Matching brand name "INFED" or generic name "Iron Dextran"

NDC	Brand Name	Generic Name
0023-6082	INFeD	Iron Dextran
0404-9879	INFED	iron dextran
52544-931	INFeD	Iron Dextran
52584-086	INFED	iron dextran
52584-931	Infed	Iron Dextran
51662-1441	IRON DEXTRAN	IRON DEXTRAN